Sr. Validation Engineer
Operations & Manufacturing
Direct Reports (list)
Reports to (title)
Director, Engineering Services
Job Summary - a concise overview of the job
The Sr. Validation Engineer is responsible for the coordination and execution of all technical activities on engineering projects from design through qualification. Routinely execute validation projects and requalification associated with manufacturing equipment, computer systems, utilities and facilities. This role plans, schedules, conducts, and coordinates validation work, monitors work for compliance to applicable codes/regulations (e.g., cGMP), accepted engineering practices, and Par standards, and ensures effective communication and coordination on projects between all disciplines and all other project participants.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Engineering Services Operating unit for Rochester, MI Operations and Manufacturing site.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Commissioning / Qualification / Validation / Requalification
- Develops Validation Protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Standard Operating Procedures (SOP) writing and review, and data review of executed validation studies, writing of final reports.
- Leads design and installation of pharmaceutical production equipment.
- Leads teams at Factory Acceptance Testing (FATs) on pharmaceutical equipment.
- Executes facility, utilities and equipment validation projects.
- Executes protocol testing and generates related final reports.
- Prepares system lifecycle support documentation (e.g. Risk Management, CAPAs, Change Controls, Deviations, GMP Investigations, Basis of Design, Process flow diagrams, Validation Test Plans, User and Functional Requirements Specifications, Design Specifications, and Requirements Trace Matrix as required).
- Manages outside consultants and technical counterparts from key vendors.
- Supports operations and maintenance staff in the operation of plant equipment and systems to ensure operating in a validated state to minimize deviations and unplanned downtime.
- Supports GMP investigations to ensure product quality and identify opportunities for improvement.
- Manages capital projects or process improvement initiatives, as required, to deliver within schedule and budget.
- Develops project schedules and maintains budgets as required.
- Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments.
- Communicates regularly with all engineers, both individually and as a group, to ensure effective two-way communication concerning operational improvements and projects.
- Manages outside consultants, contractors/vendors brought in to support design and/or project implementation.
Manufacturing Process Improvement
- Makes recommendations and takes proactive action to improve plant operations.
- Works with equipment designers and manufacturing/packaging teams to develop a cost-effective and working production process.
- Plans and implements plant improvements and expansions.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering or related studies; may be substituted with demonstrated success in pharmaceutical equipment installation/validation and automation execution.
- Minimum of 5 years’ experience with controls and instrumentation in the Pharmaceutical field.
- Experience with analyzing mechanical, electrical, process and pneumatic drawings.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
- Demonstrated knowledge of FDA, cGMP regulations and guidelines, especially 21CFR Parts 11, 210 and 211.
- Demonstrated computer proficiency: Microsoft Suite and AutoCAD.
- Demonstrated knowledge of defining critical process elements for systems and processes.
- Demonstrated knowledge of GAMP.
- Demonstrated knowledge of Computer System Validation and Sterilization qualification.
- General understanding of Lean Manufacturing and Six Sigma principles.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- Ability to work independently, efficiently, and effectively.
- Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
- Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
- Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
- Ability to handle multiple projects and assignments; Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
- Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
- Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
- Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
- Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- Occasionally be required to stand, walk, sit, climb ladders, reach with hands and arms, climb or balance, stoop or kneel, talk and hear, and use fingers and hands to feel objects, tools or controls.
- Specific vision abilities required include close vision, distance vision, depth perceptions, and the ability to adjust focus.
- Overtime may be necessary as work load’s dictate. This may include weekdays, weekends and/or holidays.
- Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 45 pounds.
- Regularly exposed to work near moving mechanical parts.
- Exposed to wet or humid conditions.
- Work in a dusty environment that will require the use of respirator.
- Exposed to outdoor weather conditions.
- Regularly exposed to high noise environments that will require the use of hearing protection (ear plugs).
- Exposed to chemicals used in the manufacturing process.
- Extended periods of standing.
- Required working on floor and in tight spaces to obtain nameplate information.
- Job will generally be performed in an office environment, but may require work in a production facility or industrial/construction job site. Conditions will vary at each location, but the conditions listed above will generally apply.